SpinalCyte filed an Investigational New Drug Application with the FDA to expand its study of CybroCell Human Dermal Fibroblasts for the treatment of degenerative disc disease.
Here are five things to know.
1. SpinalCyte's Phase 1/Phase 2 clinical trial is still enrolling. Currently, it includes 24 patients with chronic lower back pain due to degenerative disc disease. The patients are randomly assigned to one of three groups and receive intradiscal injections in one to three discs. The first group receives a saline-only placebo, the second group receives 10 million HDFs and the third group receives 10 million HDFs and platelet-rich plasma.
2. According to preliminary six-month MRI imaging data:
- 83 percent of CybroCell patients demonstrated increased disc height or no change in one or more discs compared to only 66 percent of control patients.
- More than half — 52 percent — of CybroCell-treated discs on showed either increased disc height or no change as opposed to only 38 percent of control discs
3. Over 50 percent of CybroCell-treated patients reported significant therapeutic improvement.
4. According to SpinalCyte CEO Pete O'Heeron, CybroCell has the potential to eliminate the need for opioid use in chronic back pain patients.
5. The Phase 1/Phase 2 clinical trial is the first allogeneic use of fibroblasts outside of dermatological conditions.
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